Randomised trial of water-filtered infrared A (WIRA) warming during insertion of umbilical lines
| ISRCTN | ISRCTN60384118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60384118 |
| Protocol serial number | N0453150119 |
| Sponsor | Department of Health |
| Funders | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 14/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Mitchell
Scientific
Scientific
Central Manchester & Manchester Children's University Hospitals SMH
St Mary's Hospital for Women & Children
Oxford Road
Manchester
M13 0JH
United Kingdom
| Phone | +44 |
|---|---|
| simon.mitchell@cmmc.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised trial of water-filtered infrared A (WIRA) warming during insertion of umbilical lines |
| Study objectives | To determine whether a WIRA lamp in addition to a standard incubator is more effective than standard incubator alone in preventing extremely premature babies from getting cold during insertion of umbilical lines after admission to neonatal medical unit. |
| Ethics approval(s) | Central Manchester Research Ethics Committee, ref 04/Q1407/75, 15/07/2004. |
| Health condition(s) or problem(s) studied | Neonatal Diseases |
| Intervention | Infants will be allocated to conventional warming or conventional plus WIRA during admission/stabilisation by block randomisation. |
| Intervention type | Other |
| Primary outcome measure(s) |
Axillary temperature at completion of umbilical line insertion |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 44 |
| Key inclusion criteria | Infants below 28 weeks admitted to neonatal unit |
| Key exclusion criteria | 1. Parental consent not obtained 2. Major congenital abnormality |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Central Manchester & Manchester Children's University Hospitals SMH
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | pw96 | 30/09/2015 | No | No |
Editorial Notes
14/09/2017: internal review.
